Paediatric Hepatic International Tumour Trial

Phase 3

Recruiting

• Conditions: livercancer; Livertumor; 10019815

• Registration Number: NL-OMON50638
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

For Trial Entry:
• Clinical diagnosis of HB or histologically defined diagnosis of HB or HCC.
• Age <=30 years
• Written informed consent for trial entryFor Allocation/Randomisation to
Treatment Group:
All Groups
• Written Informed Consent for trial treatment participation
• Patient assessed as fit to receive group specific treatment
• For females of child-bearing potential, a negative pregnancy test prior to
trial entry is required. Any patient who is of reproductive age must agree to
use adequate contraception for the duration of the trial.Group A (no treatment
arm)
At diagnosis:
• Resected Tumour.
• Patient meets Very Low Risk definition according to CHIC guidelines.
Group A1 - No treatment arm
• Central pathology review confirming WDF histology.
Group A2 - Treatment arm
• Central pathology review confirming non-WDF histology.
• Adequate renal function
• Adequate hematology / biochemistryGroup B
• Patient meets Low Risk definition according to CHIC Guidelines
• Adequate renal function
• Adequate hematology / biochemistryGroup C
• Patient meets Intermediate Risk definition according to CHIC Guidelines
• Adequate renal function
• Adequate cardiac function
• Adequate hematology / biochemistry

Group D
• Patient meets High Risk definition according to CHIC Guidelines
• Adequate renal function
• Adequate cardiac function
• Adequate hematology / biochemistry

Group E
• Patient has been diagnosed with HCC
• Tumour has been locally assessed as resectable
• Adequate renal function
• Adequate cardiac function
• Adequate hematology / biochemistryGroup F
• Patient diagnosed with HCC
• Tumour locally assessed as un-resectable, or metastatic HCC disease
• Adequate renal function
• Adequate cardiac function
• Adequate hematology / biochemistrySee protocol paragraph 4 for the
definitions of adequate organ function

Exclusion Criteria

• Any previous chemotherapy or currently receiving anti-cancer agents
• Recurrent disease
• Previously received a solid organ transplant
• Uncontrolled infection
• Unable to follow the protocol for any reason
• Second malignancy
• Pregnant or breastfeeding womenGroup specific exclusion criteria
All Groups:
-Hypersensitivity to any medicines used in allocated group. Group C:
-Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD)
Group D:
-Chronic inflammatory bowel disease and/or bowel obstruction
-Concomitant use with St John*s Wort which cannot be stopped prior to start of
trial treatment Group F:
-Low K, Mg or Ca which remains uncorrected by electrolyte supplementation
-Peripheral Sensory Neuropathy with functional impairment
-Personal or family history of congenital long QT syndrome
-QT/QTc interval >450msec for males and >470msec for females
-Patients who are unable to swallow tablets where an oral suspension is not
available or not approved
e Laag Risic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Group B1: Event free survival<br /><br>-Group C: Event free survival<br /><br>-Group D2/D3: Event free survival<br /><br>-Group F: Respons on chemotherapy</p><br>